December 24, 2024

On May 17, 2023, the Amgen logo was displayed outside the Amgen headquarters in Thousand Oaks, California.

Mario Tama | Getty Images

Amgen taking new method The company is trying to stand out in a crowded field where drugmakers are vying to develop the next blockbuster weight-loss drug.

This biotech company is testing a Injection treatment Unlike existing injections, it could help people lose weight Novo Nordisk and Eli Lilly and Company, and other obesity drugs in development. Amgen’s treatment, MariTide, also appears to help patients maintain weight after they stop taking the drug.

The drugmaker is also testing taking its drug once a month or even less frequently, which could offer more convenience than once-a-week medications on the market.

It’s too early to tell how competitive Amgen will be in the emerging field of weight-loss drugs, which so far has been dominated by Novo Nordisk and Eli Lilly.

Some analysts expect the market may be worth $100 billion By the end of the century, there may be room for new competitors to enter.Goldman Sachs also project By 2028, 10 million to 70 million Americans will be taking diet pills.

Existing data on Amgen’s injectable drug is promising, but it also comes from a small, early-stage Clinical Trials.The Thousand Oaks, Calif.-based company is also developing oral drugs and other treatments obesity, but no details about them were revealed.

Investors and health experts may get a better idea of ​​Amgen’s prospects later this year: The drugmaker is expected to release preliminary data from an ongoing mid-stage trial of MariTide, as well as Phase 1 data from its weight-loss drug.

It’s unclear whether Amgen’s treatment will be cheaper than existing weight-loss drugs, which cost about $1,000 a month.

Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound have pioneered a new class of obesity treatments that have attracted continued demand from patients and investors despite being expensive and with limited insurance coverage. interest.

Eli Lilly and Novo Nordisk have also struggled to provide adequate supplies of treatments, which could give other companies a chance to gain market share.

How Amgen’s treatments are different

Amgen’s drugs provide new tricks About losing weight.

Much like Wegovy and Zepbound, part of Amgen’s treatment activates a gut hormone receptor called GLP-1 to help regulate appetite in humans.

But while Zepbound activates a second hormone receptor called GIP, Amgen’s drug blocks it. Wegovy does not target GIP, which suppresses appetite like GLP-1 but may also improve the way the body breaks down sugar and fat.

Company officials said Amgen’s decision to inhibit rather than enhance GIP activity was based on genetic research showing that blocking the receptor is associated with reduced fat mass and body weight.

Some approved and experimental weight loss drugs

  • Wegos by Novo Nordisk: Approved for weekly injections of activated GLP-1
  • Eli Lilly and Company’s Zepbound: Approved for weekly injection to activate GLP-1 and GIP
  • Novo Nordisk’s Saxenda: Approved for weekly injections of activated GLP-1
  • Amgen MariTide: Monthly experimental injections to activate GLP-1 and block GIP
  • Pfizer’s Danuglipron: experimental Once-daily medication that activates GLP-1
  • VK2735 from Viking Therapeutics: Experimental weekly injections to activate GLP-1 and GIP
  • Altimmune’s Pemvidutide: Experimental weekly injections that activate GLP-1 and another gut hormone called glucagon
  • GSBR-1290 from Structure Therapeutics: Once-weekly experimental drug activates GLP-1
  • Survodutide, from Zeal Pharma, Boehringer Ingelheim: experimental Weekly injections to activate GLP-1 and glucagon

This seems to contradict how Zepbound works. Eli Lilly’s approach has proven successful: In a late-stage trial, the treatment helped obese patients lose 22.5% of their body weight after 72 weeks.

But Amgen’s MartiTide was also effective in a small, early-stage study.

Patients who received the highest monthly dose of Amgen’s drug (420 mg) lost an average of 14.5% of their body weight in just 12 weeks, according to data from d.Phase 1 trial of ata It was published last month in the journal Nature Metabolism.

Researchers have a broader debate about why blocking and activating GIP are both effective at promoting weight loss.

one theory Repeated activation of GIP receptors, as Zepbound does, ultimately causes the body to “self-regulate” and ensure there isn’t too much GIP activity, says Dr. Carolyn AppovianDirector, Center for Weight Management and Wellness at Brigham and Women’s Hospital.

This overall reduces GIP activity and is thought to essentially mimic the effect Amgen’s drug achieves when it blocks GIP receptors. But Appovian warned that “none of this is proven” and more data is needed.

This drug may lead to longer-lasting weight loss

Early trial data suggests Amgen’s treatment may help people maintain weight loss better than rivals, even though patients take the drug less frequently.

Amgen’s study enrolled 110 obese patients, but no patients with diabetes. One group of patients was randomly assigned to receive a single dose of the drug and followed for 150 days, while a second group received a dose every four weeks for three months.

Obese patients receive injections of weight-loss drugs.

Joe Baglewicz | The Washington Post | Getty Images

Dosing once a month or even less frequently

The frequency with which Amgen’s drugs are used also sets it apart. Patients must take Wegovy or Zepbound once a week, compared with MariTide, which is taken once a month.

Amgen’s trial used monthly dosing, in part because patients saw sustained weight loss regardless of whether they received one or multiple injections of the company’s drug, study authors said.

Amgen’s treatment can also stay in the body longer than existing treatments like Wegovy and Zepbound because it contains a monoclonal antibody, the authors added.

The injection pen of Eli Lilly and Company’s weight loss drug Zepbound is on display in New York City, the United States, on December 11, 2023.

Brendan McDermid | Reuters

Amgen’s MariTide “has the advantage that it lasts longer. Even if you give a high dose, you’re still exposed to the drug in your body for a month or two, so that’s a clear indication that you’re not taking it every week Once,” analyst William Blair & Company Matt Phipps told CNBC.

Phipps said people generally don’t want to inject frequently, so some patients may prefer monthly injections, such as Amgen’s MariTide, for conditions that may require long-term treatment.

But he noted that patient selection may also depend on whether the weight loss and side effects of Amgen’s drug end up being the same as those of existing weekly injections.

Amgen’s ongoing Phase 2 trial is exploring whether patients can take the drug less frequently than once a month.

Phase 2 trials will bring more clarity

Amgen’s long-term Phase 2 study of nearly 600 patients will provide a clearer picture of MariTide’s competitiveness relative to Wegovy and Zepbound. The company is exploring which dosage strength and schedule are best for patients. It expects to release preliminary trial results later this year.

Some analysts said the Phase 2 trial could help address several questions, including how well patients tolerate the different dosing regimens.

The 52-week study is testing 11 different patient groups at different dose levels and regimens. This involves starting some patients on a lower dose of the drug and then gradually increasing the dose until a higher target dose is reached.

Phipps said the dose increase may help reduce the side effects some patients experienced after taking the first dose of MariTide in the phase 1 trial.

In that trial, the safety and side effects profile of Amgen’s drug was similar to other GLP-1 drugs. Nausea and vomiting are the most common side effects, usually lasting about 72 hours.

The study showed that among the group of patients who received the highest dose, four out of eight patients dropped out before receiving their second injection due to minor gastrointestinal problems.But no other patients stopped taking the drug due to adverse events in any of the different dose groups, Amgen’s chief medical officer said. Paul Burton said at a conference earlier this month.

“Based on the phase 1 data, it’s too early to conclude that patients won’t tolerate the drug,” William Blair’s Phipps said.

Another part of Amgen’s Phase 2 trial will also examine weight loss after 52 weeks, which will provide a clearer picture of how long the drug is effective.

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